Kornimate/medical-research-clean huggingface dataset:
steroid-induced diabetes mellitus in systemic lupus erythematosus (sle) patients

Conditions: System; Lupus Erythematosus

Summary: the aim of the study is to determine the prevalence of steroid-induced diabetes mellitus (sdm) among systemic lupus erythematosus (sle) patients and identify and assess the associated risk factors .

120 sle patients who attend the sle and rheumatology clinic will be recruited into the study. all patients need to fulfil at least four criteria from the american college of rheumatology classification criteria for sle 1997(28). all patients need to be receiving corticosteroid therapy. sdm cases is defined as the development of dm after commencement of steroid treatment. prevalent cases of sdm will also be included in the study. diagnosis of dm will be made according to the american diabetes association(29), that is fasting plasma glucose ≥ 7.0 mmol/l or hba1c ≥ 6.5 or 2-h plasma glucose ≥ 11.1 mmol/l during an oral glucose tolerance test (ogtt). sle patients who receive corticosteroids treatment will be screened with fasting blood sugar during out-patient clinic visit. if fasting blood glucose level is high , an additional hba1c or ogtt will be performed. all patients included in this study will be subjected to: 1. full history taking: including age, sex, duration of the sle disease , age at onset of symptoms of sle, the progression of disease, type of corticosteroid used, dosage, duration of treatment and other types of drugs used, presence of hypertension, dyslipidemia, smoking. 2. complete clinical examination: a standardized physical examination will be performed in all patients to measure blood pressure, waist circumference and body mass index. 3. laboratory investigations: * fasting plasma glucose. * hba1c. * 2-h plasma glucose. * total cholesterol, triglyceride, low density lipoprotein (ldl) and high density lipoprotein (hdl) levels.

Eligibility criteria:
inclusion criteria * both males and females * patients aged of 18-75 years. * clinically diagnosed as sle patients. * receiving corticosteroid therapy. * prevalent cases of sdm with sle. exclusion criteria * sle patients who do not receive corticosteroid therapy. * sle patients with other types of diabetes mellitus.
efficacy and tolerability of combination varenicline with hydroxyzine as a potential smoking cessation treatment

Conditions: Smoking Cessation; Stress; Sleep Disturbance; Nausea

Summary: this open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of varenicline and with nicotine withdrawal.


Eligibility criteria:
inclusion criteria: 1. has signed the consent form and is able to read and understand the information provided in the consent form. 2. is 19 to 65 years of age (inclusive) at screening. 3. smokes at least 10 commercially available cigarettes per day for the last 12 months. 4. has an expired air carbon monoxide reading of at least 10 ppm at screening. 5. express a desire to quit smoking within the next 30 days at screening. 6. willing and able to comply with the requirements of the study. 7. participant owns a smart phone with text message and data capabilities. exclusion criteria: 1. is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ecg, concomitant medications and medical history). 2. phq-9 score greater than 9, or a score greater than 0 on item #9 ("thoughts that you would be better off dead, or of hurting yourself in some way") at screening. 3. high blood pressure (systolic \> 150 mmhg or diastolic \>95 mmhg) at screening. 4. body mass index (bmi) less than 15.0 kg/m2 or greater than 40.0 kg/m2. 5. coronary heart disease, structural cardiac disease, cardiac dysrhythmias, abnormal ecg (e.g. prolonged qtc), syncope, cardiac chest pain, or history of heart attack or heart failure. 6. has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study. 7. taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong qtc. 8. positive urine drug test for cocaine, marijuana, opiates, amphetamines or methamphetamines. 9. use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of enrollment. 10. pregnant or nursing (by self-report) or has a positive pregnancy test.
four-arm mesh for vaginal stump prolapse

Conditions: Pelvic Organ Prolapse; Sexual Function Abnormal

Summary: to estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage iii and iv vc pelvic organ prolapse quantification \[pop-q\] system staging).

pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. all patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. perineoplasty was performed additionally, if indicated. subjective and objective evaluations included pelvic organ prolapse quantification \[pop-q\] staging, preoperative and 1-year postoperative questionnaires were performed.

Eligibility criteria:
inclusion criteria: * pelvic organ prolapse quantification (popq) iii and iv vc after hysterectomy exclusion criteria: * malignant diseases * unability to understand informed consent

Keywords: vaginal stump prolapse sexual function quality of life
13c-spirulina nitrogen content gebt study

Conditions: Gastroparesis

Summary: the purpose of this study is to determine whether there is a difference in the human in vivo response to 13c-spirulina meals manufactured using 13c-spirulina containing different levels of protein (as measured by %nitrogen).

in this study participants will be administered the standard fda-approved gebt in which the test meals contain 13c-spirulina that has 7.9% nitrogen content. on a second occasion, a low nitrogen gebt in which the test meal will contain 13c-spirulina with a 6.4% nitrogen content will be administered. both sets of gebts have been manufactured under full cgmps and both will be administered to the participants according to the fda-approved gebt labeling. the two in vivo results of the two independent gebt test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13co2 signaling.

Eligibility criteria:
inclusion criteria: * males and females, 18-85 years old at time of signing consent form * ability to eat test meal and provide breath samples exclusion criteria: * history or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome * symptoms consistent with delayed gastric emptying * history of abdominal surgery except appendectomy * use of any medications that may alter gastric motility within two days of the study * use of narcotics or anticholinergics within two days of the study * females on hormone replacement therapy other than birth control medications * receipt of an investigational drug within 4 weeks of the study * pregnancy * intolerance or allergy to any component of gastric emptying breath test meal * history of neurologic or psychiatric disorder

Keywords: gastroenterology gastric emptying breath test
smokefreesgm español pilot, beta testing a text-based smoking cessation intervention for sexual and gender minority(sgm) groups preferring spanish language

Conditions: Smoking Cessation

Summary: the purpose of this study is to test the usability, engagement and acceptability of smokefreesgm español, a culturally and linguistically tailored version of smokefreesgm, among spanish-speaking sgm smokers.


Eligibility criteria:
inclusion criteria: * currently live in the united states * have smoked at least 100 cigarettes in their lifetime, smoke every day, and smoke ≥ 5 cigarettes a day * are willing to quit smoking in the next 15 days * have a cell phone number with an unlimited short message service (sms) plan * have a positive cotinine saliva test to indicate their smoking status * speak fluent spanish exclusion criteria: * have a prepaid cell phone plan (pay-as-you-go plan) * have a cell phone number that does not work and/or is registered to someone else * have inadequate equipment/devices (i.e., webcam, speakers, mic) for participating in telehealth sessions via microsoft teams, webex, or zoom and cannot meet in-person * pregnant or breastfeeding persons (nicotine patches are not generally recommended to this groups since nicotine can affect fetal and neonatal brain development) * contraindication for nicotine patches. absolute contraindications include: severe eczema or serious skin conditions, allergy to nicotine patches, pregnancy, breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer disease, arrhythmia, or uncontrolled blood pressure. potential contraindications include: stroke in the past 6 months, insulin therapy, and a current diagnosis of liver, kidney, or heart disease. study participants reporting a potential contraindication will require approval from their primary care provider and/or other treating physician (e.g., psychiatrist) to use nicotine patches. if the request is denied or not returned in 2 weeks, potential study participants will be excluded from the study. * current use of tobacco cessation medications * current use of tobacco products other than cigarettes or electronic nicotine delivery systems (ends) (i.e., (e.g., cigar, cigarillo, little cigar, pipe, hookah) * enrollment in another smoking cessation study

Keywords: lesbian, gay, bisexual, transgender, queer/questioning (one's sexual or gender identity), and intersex(lgbtqi)
a safety and preliminary efficacy study of sbt6290 alone and in combination with pd-(l)1 inhibitors in select advanced solid tumors

Conditions: Urothelial Carcinoma; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck; Hormone Receptor-positive/HER2-negative Breast Cancer

Summary: this is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate sbt6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with nectin-4 expression.

this is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, immunogenicity, and preliminary antitumor activity of sbt6290 administered subcutaneously (sc) as a monotherapy and in combination with pembrolizumab in solid tumors associated with nectin-4 expression. there are 4 parts to this study: * part 1: a dose escalation of sbt6290 monotherapy * part 2: tumor-specific expansion cohorts evaluating sbt6290 monotherapy administered at the recommended phase 2 dose (rp2d) identified in part 1 * part 3: a dose escalation of sbt6290 in combination with pembrolizumab * part 4: an expansion cohort of sbt6290 in combination with pembrolizumab administered at the rp2d identified in part 3 for the combination

Eligibility criteria:
key inclusion criteria: * locally advanced or metastatic solid tumors associated associated with nectin-4 expression (locally advanced or metastatic urothelial carcinoma, tnbc, nsclc, scchn, and hr+/her2- negative breast cancer) * measurable disease per the the response evaluation criteria in solid tumors (recist) version 1.1 criteria * tumor lesion amenable for biopsy available to submit for retrospective baseline testing of nectin-4; archived tumor tissue may be acceptable depending upon study part detailed criteria * ecog performance status of 0 or 1 * adequate organ and marrow function note: other protocol-defined inclusion/exclusion criteria may apply. key exclusion criteria: * history of allergic reactions to certain components of study treatments * untreated brain metastases * currently active (or history of) autoimmune disease * taking the equivalent of \>10 mg / day of prednisone * uncontrolled or clinically significant interstitial lung disease (ild) * history of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living * hiv infection, active hepatitis b or hepatitis c infection note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: sbt6290 breast cancer urothelial carcinoma non-small cell lung cancer squamous cell carcinoma of head and neck tlr8 nectin-4 pembrolizumab (keytruda)
correlation between the change in the antero-posterior diameter of the pelvic side and the incidence of post-partum urinary incontinence

Conditions: Postpartum Urinary Incontinence

Summary: during pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. the investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic floor muscles affects postpartum urinary incontinence; secondly to study the correlation between the use of perineal gymnastics, the incidence of postpartum urinary incontinence, and the strength of floor contraction.

as part of the gynecologic ultrasound that is routinely performed, a transperineal scan will be performed, at rest and during maximal contraction to measure the lower portion of the pelvic floor groove. i order tho achieve this, doctors will illustrate to participants first verbally and then with the visual aid of the ultrasound monitor, how to contract the pelvic floor muscles. transperineal ultrasound is performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora. such ultrasound does not involve internal investigations and is in no way painful. the duration of the additional ultrasound scan involves a few minutes. in addition, in order to assess the presence of typical symptoms of urinary incontinence, the participant will undergo a standardized validated questionnaire in the italian language, called iciq-ui sf, consisting of a series of questions that will investigate the type of urinary incontinence, its severity and its impact on her quality of life in the four weeks prior to administration. after delivery, the participant's medical records will be consulted and some data regarding the participant (age, ethnicity, height, weight, bmi, parity, gestational age at the time of delivery), the delivery (duration of stage ii labor, mode of delivery, any vagino-perineal laceration and its degree) and the newborn (weight and head circumference measurement) will be recorded.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * completion of delivery by vaginal delivery, vaginal delivery with obstetric suction cup or cesarean section * acquisition of informed consent form exclusion criteria: * presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure). * presence of clinically demonstrable vulvar or vaginal infection

Keywords: incontinence
trial comparing 19 and 25g needles for fine needle aspiration (fna) of solid pancreatic mass lesions greater than 35mm

Conditions: Pancreatic Cancer

Summary: this study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (eus) procedures. patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made. the biopsy can be performed using either a 19 or 25-gauge needle. the purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.

endoscopic ultrasound-guided fine needle aspiration (eus-fna) can be performed using the 25, 22 or 19 gauge (g) needles. randomized trials have shown that all three needles are safe and perform equally well. however, in a retrospective study, the diagnostic sensitivity of eus-fna for pancreatic masses that measured more than 35mm was less compared to smaller size masses. this is because larger size tumors have more necrosis and it is difficult to identify cancer cells in them to make a diagnosis. therefore, more biopsies must be performed in larger size tumors to establish a diagnosis. in previous studies it has been shown that the larger 19g needles procure larger and better quality tissue. therefore, our hypothesis is that, when a larger 19g needle is used to fna tumors more than 35mm, a diagnosis can be achieved with fewer passes.

Eligibility criteria:
inclusion criteria: all patients referred to florida hospital endoscopy unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (ct) that require fna. exclusion criteria: * age \< 19 years * unable to safely undergo eus for any reason * coagulopathy (inr \>1.6, prothrombin time \>18secs, thrombocytopenia \<80,000 cells/ml) * unable to consent * non-english speaking patients * participation in any other clinical trial (excluding registries or databases)

Keywords: pancreas cancer eus-fna 19gauge 25gauge 35mm mass
the effect of oral bifidobacterium on exogenous creatine absorption in adult subjects

Conditions: Depression

Summary: the purpose of this clinical trial is to learn if bifidobacterium has better antidepressant-like effects by enhancing creatine absorption in adults. the main questions to be answered are does bifidobacterium combined with creatine have better antidepressant effects? does bifidobacterium enhance exogenous creatine uptake? researchers will compare bifidobacterium combined with creatine to creatine or bifidobacterium to see if bifidobacterium combined with creatine has better antidepressant effects. participants will: take bifidobacterium, creatine or placebo every day for 4 weeks. keep a diary of their symptoms and collect blood samples.


Eligibility criteria:
inclusion criteria for depression: * adults age 18-60 years inclusive. * current diagnosis of major depression disorder (mdd) identified by the structured clinical interview for diagnostic and statistical manual of mental disorders-5 (scid-5). * current hamilton depression scale 17 score of \> 16. * bmi (body mass index) between 18 and 28 kg/m² * right-handed exclusion criteria: * diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the scid-5. * history of or current diagnosis of acute kidney injury (aki), chronic kidney disease (ckd) or end-stage renal disease (esrd) * history of seizure disorder * current serious suicide risk identified by the columbia severity suicide rating scale * previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome * antibiotic use in last 30 days * probiotics use in last 30 days * positive pregnancy test * breastfeeding
to assess efficacy of nutritional therapy in secondary prophylaxis of hepatic encephalopathy versus lactulose in patients with liver cirrhosis.

Conditions: Liver Cirrhosis

Summary: the study will be conducted on patients attending /admitted to department of hepatology from april 2017 to december 2018 at ilbs, new delhi . clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. other patients will continue diet that they were receiving before along with lactulose. previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. all subjects will be followed up every month for treatment compliance and for development of any complications.


Eligibility criteria:
inclusion criteria: 1. liver cirrhosis (child b or child c class) 2. age between 18-60 years 3. history of recovery from episodeof overt hepatic encephalopathy (west-haven grade 1 and above) in last 12 months. exclusion criteria: 1. evidence of overt hepatic encephalopathy at the time of enrollment 2. history of taking lactulose, rifaximin, neomycin, metronidazole, l-ornithine l-aspartate or probiotics in past 7 days 3. alcohol intake during past 6 weeks 4. receiving secondary prophylaxis for spontaneous bacterial peritonitis 5. previous transjugular intrahepatic portosystemic shunts or shunt surgery 6. significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as alzheimer's disease, parkinson's disease and non hepatic metabolic encephalopathies 7. receiving psychoactive drugs, promotility and hypomotility drugs 8. hepatocellular carcinoma 9. electrolyte abnormality (serum sodium \<125meq/l or serum potassium \<2.5meq/l) 10. intercurrent infection such as spontaneous bacterial peritonitis 11. patients of acute on chronic liver failure (aclf).
ag-013736 (axitinib) in patients with poor prognosis acute myeloid leukemia (aml) or myelodysplastic syndrome (mds)

Conditions: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome

Summary: the study tests the safety and efficacy of axitinib in patients who have the hematologic disease of acute myeloid leukemia or myelodysplastic syndrome. the study tests patients who have poor prognosis before entering the study.


Eligibility criteria:
inclusion criteria: * poor prognosis aml or mds * histological confirmation of diagnosis * white blood cell count less than or equal to 30,000/mm3 * adequate hepatic and renal function documented within 14 days prior to registration * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * no evidence of preexisting uncontrolled hypertension * not a suitable candidate for chemotherapy * no prior systemic chemotherapy treatment for aml or mds or treatment with an anti-angiogenesis agent exclusion criteria: * patients must not have exclusion criteria. * candidate for chemotherapy * patients with aml m3 (acute promyelocytic leukemia) * conditions that might confound the evaluation of safety or efficacy or increase patient risk.
study of vir-2482 in healthy volunteers

Conditions: Influenza A

Summary: this is a phase 1 study in which healthy volunteers will receive vir-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of vir-2482 in preventing influenza a illness.


Eligibility criteria:
inclusion criteria: * healthy male or female age 18 to \< 65 years * body mass index (bmi) of 18.0 kg/m\^2 to 32.0kg/m\^2 exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * history of influenza-like illness or confirmed influenza infection within 3 months prior to randomization. * fever-like illness within 5 days of randomization. * history or clinical evidence of conditions considered high risk for developing influenza-related complications.

Keywords: influenza a